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The effect of curcumin-piperine supplementation on inflammatory factors and clinical signs in patients with rheumatoid arthritis: a double-blind clinical trial study

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History
# Registration date Revision Id
3 2025-07-04, 1404/04/13 346471
2 2022-08-07, 1401/05/16 236886
1 2021-08-10, 1400/05/19 193472
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  • Protocol summary

    This study is a clinical trial with a control and randomized parallel double-blind group, in which 50 patients with rheumatoid arthritis will be divided into two groups receiving curcumin-piperine supplement (n = 25) and placebo (n = 25).
    This study is a clinical trial with a control and randomized parallel double-blind group, in which 54 patients with rheumatoid arthritis will be divided into two groups receiving curcumin-piperine supplement (n = 27) and placebo (n = 27).
    این مطالعه به صورت یک کارآزمایی بالینی دارای گروه کنترل و تصادفی شده موازی دو سو کور می باشد، که در آن 50 فرد مبتلا به آرتریت روماتوئید به دو گروه دریافت کننده مکمل کورکومین-پیپرین (25 نفر) و دارونما (25 نفر) تقسیم خواهند شد.
    این مطالعه به صورت یک کارآزمایی بالینی دارای گروه کنترل و تصادفی شده موازی دو سو کور می باشد، که در آن 54 فرد مبتلا به آرتریت روماتوئید به دو گروه دریافت کننده مکمل کورکومین-پیپرین (27 نفر) و دارونما (27 نفر) تقسیم خواهند شد.
    1) Intervention group (n = 25) daily one capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine 2) control group (n = 25) daily placebo capsule (500 mg of maltodextrin) with diet and activity recommendations They will receive a body; patients will be given a supplement can for one month to evaluate the use of supplements. The patient must return the supplement can monthly and specify the number inside.
    1) Intervention group (n = 27) daily one capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine 2) control group (n = 27) daily placebo capsule (505 mg of maltodextrin) with diet and activity recommendations.
    1)گروه مداخله( 25 نفر) روزانه یک کپسول حاوی کورکومین پیپرین (حاوی 500 میلی گرم عصاره کورکومین و 5 میلی گرم پیپرین 2) گروه کنترل(25 نفر) روزانه یک کپسول دارونما (500 میلی گرم مالتودکسترین) به همراه توصیه های رژیم غذایی و فعالیت بدنی دریافت خواهند کرد؛جهت ارزیابی مصرف مکمل ها، به بیماران قوطی مکمل برای یکماه داده می شود.
    1)گروه مداخله( 27 نفر) روزانه یک کپسول حاوی کورکومین پیپرین (حاوی 500 میلی گرم عصاره کورکومین و 5 میلی گرم پیپرین 2) گروه کنترل(27 نفر) روزانه یک کپسول دارونما (505 میلی گرم مالتودکسترین) به همراه توصیه های رژیم غذایی و فعالیت بدنی دریافت خواهند کرد.
    Clinical signs, inflammation indices such as quantitative CRP and ESR, and oxidative stress factors such as TAC and TOS
    Clinical signs, inflammation indices such as quantitative CRP and ESR, and oxidative stress factors such as Total antioxidant capacity (TAC), Superoxide dismutase (SOD), Malondialdehyde (MDA), Rheumatoid factor (RF)
    علائم بالینی، شاخص التهابی مانند CRP کمی و ESR و شاخص های استرس اکسیداتیو مانند TAC و TOS
    علائم بالینی، شاخص التهابی مانند CRP کمی و ESR و شاخص های استرس اکسیداتیو مانند ظرغیت تام آنتی اکسیدانی (TAC)، مالون دآلدهید (MDA) و سوپراکسید دیس موتاز (SOD) و فاکتور روماتویید (RF)

  • General information

    50
    54
    Age change of the participants and some outcomes of the study
    To enhance the statistical power of the study, we propose increasing the sample size to 54 participants and distinguishing between primary and secondary outcomes.
    تغییر سن شرکت کنندگان و برخی پیامدهای مطالعه
    برای افزایش قدرت آماری مطالعه، پیشنهاد می‌کنیم حجم نمونه به 54 شرکت‌کننده افزایش یابد و برخی متغیرهای اولیه و ثانویه تفکیک شوند
    Willingness to participate in the study
    Age: 30-70 years
    Complete informed consent
    Rheumatoid arthritis according to the rheumatologist according to the criteria of the American College of Rheumatology 2010
    Disease activity score higher than 1/5 and total soft joint count (TJC) and swollen joint count (SJC) higher than 8
    Willingness to participate in the study
    Age: 30-70 years
    Complete informed consent
    Rheumatoid arthritis according to the rheumatologist according to the criteria of the American College of Rheumatology 2010
    Disease activity score higher than 5.1 and total soft joint count (TJC) and swollen joint count (SJC) higher than 8
    تمایل به شرکت در مطالعه
    سن 30-70 سال
    تکمیل رضایت نامه آگاهانه
    ابتلا به آرتریت روماتویید طبق نظر متخصص روماتولوژی بر اساس معیار کالج روماتولوژی امریکا 2010
    امتیاز فعالیت بیماری بالاتر از 1/5 و مجموع امتیاز شمارش مفاصل نرم (TJC) و شمارش مفصل متورم (SJC) بالاتر از 8
    تمایل به شرکت در مطالعه
    سن 30-70 سال
    تکمیل رضایت نامه آگاهانه
    ابتلا به آرتریت روماتویید طبق نظر متخصص روماتولوژی بر اساس معیار کالج روماتولوژی امریکا 2010
    امتیاز فعالیت بیماری بالاتر از 5.1 و مجموع امتیاز شمارش مفاصل نرم (TJC) و شمارش مفصل متورم (SJC) بالاتر از 8
    Pregnancy and lactation
    Smoking
    Heart, lung, kidney, hepatitis, cirrhosis, biliary and immune system disorders, hypertension, diabetes, hypothyroidism, Cushing's syndrome
    Weight loss and bariatric surgery in the last year.
    Lack of following a special diet and herbal supplements
    Pregnancy and lactation
    Smoking
    Heart, lung, kidney, hepatitis, cirrhosis, biliary and immune system disorders, hypertension, uncontrolled diabetes, hypothyroidism, Cushing's syndrome
    Weight loss and bariatric surgery in the last year.
    Lack of following a special diet and herbal supplements
    بارداری و شیردهی
    مصرف دخانیات
    ابتلا به بیماری های قلبی، ریوی، کلیوی، هپاتیت، سیروز، اختلالات صفراوی و سیستم ایمنی، فشار خون بالا، دیابت، هیپوتیروئیدیسم ، سندرم کوشینگ
    کاهش وزن و جراحی باریاتریک در یک سال اخیر.
    عدم پیروی از رژیم غذایی خاص و مکمل های گیاهی
    بارداری و شیردهی
    مصرف دخانیات
    ابتلا به بیماری های قلبی، ریوی، کلیوی، هپاتیت، سیروز، اختلالات صفراوی و سیستم ایمنی، فشار خون بالا، دیابت کنترل نشده، هیپوتیروئیدیسم ، سندرم کوشینگ
    کاهش وزن و جراحی باریاتریک در یک سال اخیر.
    عدم پیروی از رژیم غذایی خاص و مکمل های گیاهی

  • Primary outcomes

    #1
    Elisa
    Colorimetric method
    الایزا
    روش رنگ سنجی
    #2
    Total Oxidant Status (TOS)
    C-reactive protein (CRP)
    وضعیت تام اکسیدان
    پروتئین واکنشگر C
    Elisa
    Colorimetric analysis method and by autoanalyzer
    الایزا
    روش کلریمتریک و بوسیله دستگاه اتوآنالایزر
    #3
    C-reactive protein (CRP)
    ESR
    پروتئین واکنشگر C
    سرعت رسوب گلبول قرمز
    Colorimetric analysis method and by autoanalyzer
    Enzymatic method
    روش کلریمتریک و بوسیله دستگاه اتوآنالایزر
    روش آنزیمی
    #4
    ESR
    Clinical signs
    سرعت رسوب گلبول قرمز
    علائم بالینی
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Enzymatic method
    Diagnosis by a specialist and validated questionnaires
    روش آنزیمی
    تشخیص توسط متخصص و پرسش نامه های معتبر
    #5
    Clinical signs
    Superoxide dismutase (SOD)
    علائم بالینی
    سوپر اکسید دیس موتاز
    Diagnosis by a specialist
    Colorimetric method
    تشخیص توسط متخصص
    روش رنگ سنجی
    #6
    empty
    Malondialdehyde (MDA)
    empty
    مالون د آلدهید
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مداخله
    empty
    Colorimetric method
    empty
    روش رنگ سنجی
    #7
    empty
    Rheumatoid factor (RF)
    empty
    فاکتور روماتویید
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مداخله
    empty
    ELISA
    empty
    الایزا

  • Intervention groups

    #1
    Control group: They will receive one placebo capsule (500 mg of maltodextrin) daily with diet and exercise recommendations. Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition.
    Control group: They will receive one placebo capsule (505 mg of maltodextrin) daily with diet and exercise recommendations. Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition.
    گروه کنترل: روزانه یک کپسول دارونما (500 میلی گرم مالتودکسترین) به همراه توصیه های رژیم غذایی و فعالیت بدنی دریافت خواهند کرد. توصیه های غذایی عمدتا شامل تاکید بر مصرف مواد غذایی حاوی آنتی اکسیدان در جهت کاهش التهاب و جلو گیری از افزایش التهابمانند خانواده کلم ها و توت می باشد. همچنین فعالیت بدنی در حد اندک که باعث افزایش مشکلات ناشی از آرتریت روماتوئید نشود و به بهبود شرایط کمک کند به افراد توصیه می شود.
    گروه کنترل: روزانه یک کپسول دارونما (505 میلی گرم مالتودکسترین) به همراه توصیه های رژیم غذایی و فعالیت بدنی دریافت خواهند کرد. توصیه های غذایی عمدتا شامل تاکید بر مصرف مواد غذایی حاوی آنتی اکسیدان در جهت کاهش التهاب و جلو گیری از افزایش التهابمانند خانواده کلم ها و توت می باشد. همچنین فعالیت بدنی در حد اندک که باعث افزایش مشکلات ناشی از آرتریت روماتوئید نشود و به بهبود شرایط کمک کند به افراد توصیه می شود.

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Gholamreza Askari
    Full name of responsible person - Persian: غلامرضا عسکری
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: specialist
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hezarjarib Ave
    Street address - Persian: خیابان هزارجریب
    City - English: ISFAHAN
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81746-73461
    Phone: +98 31 3668 1378
    Mobile: +98 913 266 3418
    Fax:
    Email: askari@mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Bagherniya
    Full name of responsible person - Persian: محمد باقرنیا
    Position - English: Assistant professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hezarjarib Ave
    Street address - Persian: خیابان هزارجریب
    City - English: ISFAHAN
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81746-73461
    Phone: +98 31 3668 1378
    Mobile: +98 913 210 1627
    Fax:
    Email: bagherniya@nutr.mui.ac.ir
    Web page address:

Protocol summary

Study aim
The effect of curcumin-piperine supplementation on inflammatory factors and clinical signs in patients with rheumatoid arthritis
Design
This study is a clinical trial with a control and randomized parallel double-blind group, in which 54 patients with rheumatoid arthritis will be divided into two groups receiving curcumin-piperine supplement (n = 27) and placebo (n = 27).
Settings and conduct
In this study, people with rheumatoid arthritis will be admitted to Al-Zahra Hospital. Random allocation will be done using a random number table. Entry of individuals and assignment of each person to one of the two groups will be done by the relevant specialist. Curcumin-piperine supplement and placebo will be packaged in similar boxes and the researcher and patients will not be informed of the contents of the packages until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, age 30-70 years, completing informed consent.Rheumatoid arthritis According to the rheumatologist Inclusion criteria: Pregnancy and lactation Smoking Underlying diseases, weight loss and bariatric surgery in a recent years, lack of special diet and herbal supplements
Intervention groups
1) Intervention group (n = 27) daily one capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine 2) control group (n = 27) daily placebo capsule (505 mg of maltodextrin) with diet and activity recommendations.
Main outcome variables
Clinical signs, inflammation indices such as quantitative CRP and ESR, and oxidative stress factors such as Total antioxidant capacity (TAC), Superoxide dismutase (SOD), Malondialdehyde (MDA), Rheumatoid factor (RF)

General information

Reason for update
To enhance the statistical power of the study, we propose increasing the sample size to 54 participants and distinguishing between primary and secondary outcomes.
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N53
Registration date: 2021-08-10, 1400/05/19
Registration timing: prospective

Last update: 2025-07-08, 1404/04/17
Update count: 2
Registration date
2021-08-10, 1400/05/19
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin-piperine supplementation on inflammatory factors and clinical signs in patients with rheumatoid arthritis: a double-blind clinical trial study
Public title
Evaluation of the effect of curcumin-piperine in the treatment of rheumatoid arthritis
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Age: 30-70 years Complete informed consent Rheumatoid arthritis according to the rheumatologist according to the criteria of the American College of Rheumatology 2010 Disease activity score higher than 5.1 and total soft joint count (TJC) and swollen joint count (SJC) higher than 8
Exclusion criteria:
Pregnancy and lactation Smoking Heart, lung, kidney, hepatitis, cirrhosis, biliary and immune system disorders, hypertension, uncontrolled diabetes, hypothyroidism, Cushing's syndrome Weight loss and bariatric surgery in the last year. Lack of following a special diet and herbal supplements
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner. https://www.sealedenvelope.com/simple-randomiser/v1/lists In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age and sex. It is noteworthy that participants and outcome assessors will not be aware of patient grouping and will be blind to it.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to conduct this research in a double-blind manner, before starting the study, the total capsules are coded in A and B by a person other than the researcher, so that both groups do not know the type of capsules received by both groups. To keep track of people in the study groups using the capsules, they will be contacted weekly by phone or text message and will be reminded of the capsule use. To check patients' compliance, curcumin and placebo capsules are given to them on a monthly basis and they are asked to deliver the previous capsule pack so that we can give them the new pack. Capsule use is also reminded and evaluated by weekly phone calls and text messages.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.068

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor

Primary outcomes

1

Description
Total antioxidant capacity (TAC)
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric method

2

Description
C-reactive protein (CRP)
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric analysis method and by autoanalyzer

3

Description
ESR
Timepoint
Beginning and end of the study
Method of measurement
Enzymatic method

4

Description
Clinical signs
Timepoint
Beginning and end of the study
Method of measurement
Diagnosis by a specialist and validated questionnaires

5

Description
Superoxide dismutase (SOD)
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric method

6

Description
Malondialdehyde (MDA)
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric method

7

Description
Rheumatoid factor (RF)
Timepoint
Beginning and end of the study
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Take one capsule containing curcumin piperine daily (containing 500 mg curcumin extract and 5 mg piperine) for 12 weeks. They will also receive diet and exercise advice.Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition.
Category
Treatment - Drugs

2

Description
Control group: They will receive one placebo capsule (505 mg of maltodextrin) daily with diet and exercise recommendations. Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Ghulam Reza Askari
Street address
Sofe Boulevard
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
askari@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Hezar Jarib
City
ISFAHAN
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
ISFAHAN
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Email
bagherniya@nutr.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The collected deidentified for the primary outcome measure only will be shared.
When the data will become available and for how long
12 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
To conduct similar studies
From where data/document is obtainable
askari@mui.ac.ir
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request.
Comments
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